Catalog Number

-

Brand Name

Lightning Needle

Version/Model Number

LTN80-O

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141910,K141910

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

6dcc57c9-3369-463b-8a71-6b4359538249

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 23, 2019

Package DI Number

M896LTN80O1

Quantity per Package

1

Contains DI Package

M896LTN80O0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-